60 Participants NeededMy employer runs this trial

Acceptance and Commitment Therapy for Cystic Fibrosis

VO
Overseen ByVirginia O'Hayer, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Thomas Jefferson University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new self-help therapy for adults with cystic fibrosis who also experience anxiety or depression. The treatment, known as the ACT with CF Self-Help Toolkit, is a type of talk therapy accessible via smartphone. The researchers aim to determine if this self-help version can improve mental health and help individuals live in line with their values. Participants must have cystic fibrosis and experience symptoms of anxiety or depression. As an unphased trial, this study provides an opportunity to contribute to innovative mental health solutions tailored for cystic fibrosis.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on therapy rather than medication changes.

What prior data suggests that the ACT with CF Self-Help Toolkit is safe for adults with cystic fibrosis?

Research has shown that the ACT with CF Self-Help Toolkit aims to boost mental well-being in adults with cystic fibrosis. Acceptance and Commitment Therapy (ACT) has helped previous patients reduce anxiety and depression. This therapy is popular because it focuses on improving how individuals manage thoughts and feelings rather than relying on medication.

Past studies found that ACT with CF improved mental health in people with CF more effectively than other therapies. Participants reported feeling less anxious and stressed. As a self-help version of a proven therapy, this toolkit is likely safe and easy to use.

This study tests a self-help toolkit, so it involves no drugs, reducing the risk of side effects common with medication-based treatments. However, individual experiences with any therapy may vary.12345

Why are researchers excited about this trial?

Researchers are excited about the ACT With CF Self-Help Toolkit because it offers a novel, self-guided approach for people with cystic fibrosis (CF) to manage their condition, beyond the typical medical treatments like airway clearance techniques and medications. This toolkit provides educational resources and practical exercises that empower patients to take control of their health, potentially improving their quality of life. Unlike traditional treatments that focus primarily on physical symptoms, this method emphasizes mental and emotional well-being, which is often overlooked in CF care. By incorporating psychological strategies, the toolkit aims to support patients in a holistic manner, making it a promising adjunct to existing therapies.

What evidence suggests that the ACT with CF Self-Help Toolkit might be an effective treatment for anxiety and depression in adults with cystic fibrosis?

Research has shown that Acceptance and Commitment Therapy (ACT) can reduce depression and anxiety while improving quality of life. For adults with cystic fibrosis (CF), ACT has proven more effective in enhancing mental health than traditional therapy methods. This trial will compare two groups: one receiving immediate access to the ACT with CF Self-Help Toolkit and another on a waitlist. Studies have found that both regular ACT and self-help versions, like the ACT with CF Self-Help Toolkit, effectively lower depression and anxiety. The toolkit aims to enhance psychological flexibility, helping individuals better manage difficult situations. Early findings suggest that this self-help approach may be particularly beneficial for adults with CF who face mental health challenges.13678

Are You a Good Fit for This Trial?

This trial is for adults (18+) with cystic fibrosis who have mild or higher symptoms of anxiety or depression. People can't join if they have psychosis, recent suicide attempts, severe psychiatric issues, or other medical problems that would make participation unsafe.

Inclusion Criteria

PHQ-9 score >4 or GAD-7 score >4
I am 18 years old or older.
I have been diagnosed with cystic fibrosis.

Exclusion Criteria

Presence of psychotic disorder or symptoms
I have a history of suicide attempts or recent suicidal thoughts.
Presence of psychiatric disorders that interfere with participation in the study, judged by the study or treating clinician
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (virtual)

Immediate Treatment

Participants receive immediate access to the ACT with CF Self-Help Toolkit and use it for 6 weeks

6 weeks
Self-guided, virtual

Waitlist Control

Participants wait for 6 weeks before receiving the ACT with CF Self-Help Toolkit

6 weeks
Self-guided, virtual

Follow-up

Participants are monitored for changes in anxiety, depression, and psychological flexibility after treatment

3 months
Questionnaires at 6 weeks and 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • ACT with CF Self-Help Toolkit

Trial Overview

The study tests a self-help version of Acceptance and Commitment Therapy (ACT) designed for people with cystic fibrosis. Participants are randomly assigned to use the ACT toolkit on their smartphone right away or after waiting.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: WaitlistExperimental Treatment2 Interventions
Group II: Immediate TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials
475
Recruited
189,000+

Boomer Esiason Foundation

Collaborator

Citations

NCT07436351 | ACT With CF Self-Help Toolkit

ACT with CF Self Help Toolkit will prove more effective than Waitlist Control in reducing cognitive fusion, depression and anxiety, and improving psychological ...

ACT with CF: A randomized trial of acceptance and ...

ACT demonstrated greater improvements in psychological functioning at 6-weeks (mean score = 57.3 [51.6, 63.0]) relative to SP (mean score = 67.8 ...

Efficacy of Internet-Based Acceptance and Commitment ... - PMC

A growing body of evidence shows that ACT can reduce depressive symptoms, anxiety, stress, and psychological distress and improve quality of life (QoL) in ...

ACT with CF-Self-Help-Toolkit – Participants Needed. ...

This Toolkit is aimed at reducing anxiety and depression and improving psychological flexibility in adults with CF. The toolkit involves 6 ...

515 ACT with CF self-help toolkit | Request PDF

Results: Both treatments effectively reduced depression over 10 weeks, with ACT showing a slight advantage over tCBT. Surprisingly, students who ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39626332/

ACT with CF: A randomized trial of acceptance and ...

Conclusions: ACT with CF was superior to SP in improving psychological functioning among adults with CF and elevated psychological distress, ...

RightCare cystic fibrosis toolkit

The toolkit includes a self-assessment questionnaire which provides a method for assessment and benchmarking of current services. This toolkit should be used in ...

ACT With CF Self-Help Toolkit | NCT07436351

~Adults with cystic fibrosis are at increased risk for anxiety and depression. This study examines whether a patient-facing therapy, ACT with CF - Self Help ...